LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
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Purpose
The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.
| Condition | Intervention |
|---|---|
|
Children |
Device: Laryngeal Mask Airway Device: air-QTM Intubating Laryngeal Airway |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children |
- Oropharyngeal leak pressure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Laryngeal Mask airway (LMA)
children weighing 20 to 30 kg
|
Device: Laryngeal Mask Airway
Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
Other Name: Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA)
|
|
Intubating Laryngeal Airway (ILA-SP)
Children weighing 20-30 kg
|
Device: air-QTM Intubating Laryngeal Airway
Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
Other Name: air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA
|
Detailed Description:
The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.
Eligibility| Ages Eligible for Study: | 3 Years to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device
Inclusion Criteria:
- Children undergoing general anesthesia using a supraglottic airway device
- 3 to 9 years of age
- 20 to 30 kilograms in weight
Exclusion Criteria:
- History of a difficult airway
- Active gastrointestinal reflux
- Active upper respiratory tract infection
Contacts and Locations| United States, Illinois | |
| Childrens Memorial Hospital | |
| Chicago, Illinois, United States, 60618 | |
| Principal Investigator: | Narasimhan Jagannathan, MD | Childrens Memorial Hospital |
More Information
Publications:
| Responsible Party: | Narasimhan Jagannathan, primary investigator, Children's Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01385761 History of Changes |
| Other Study ID Numbers: | IRB#2011-14642 |
| Study First Received: | June 28, 2011 |
| Last Updated: | March 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
|
Supraglottic airway devices |
ClinicalTrials.gov processed this record on May 19, 2013